Puregon - instructions for use, analogs, reviews and release forms (injections in ampoules for injection 50 IU, 100 IU, 150 IU, 200 IU, 300 IU, 600 IU and 900 IU in solution, pen PEN) of the drug for infertility in women and stimulation of ovulation with IVF

In this article, you can read the instructions for using the drug Pureghon. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Puregon in their practice. A big request is to actively add their comments about the drug: the medicine helped or did not help get rid of the disease and condition, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Puregon in the presence of existing structural analogues. Use to treat infertility in women and stimulate ovulation, including IVF (in vitro fertilization), as well as,what to do when pregnancy comes and breastfeeding.

Pureghon - recombinant follicle-stimulating hormone (FSH), which is obtained by recombinant DNA technology, using the culture of Chinese hamster ovary cells, into which the genes of human FSH subunits are introduced. The primary amino acid sequence of recombinant DNA is identical to that of natural human FSH. There are small differences in the structure of the hydrocarbon chain.

FSH provides normal growth and maturation of follicles and the synthesis of sex steroid hormones. The level of FSH in women is a factor determining the onset and duration of follicular development, as well as the time of their maturation. Thus, Puregon can be used to stimulate the development of follicles and the synthesis of estrogens in certain disorders of the ovaries. In addition, Puregon is used to induce multiple development of follicles during artificial insemination (for example, in extracorporeal fertilization or embryo transfer (IVF or PE), intrauterine insemination (ICU) and intracytoplasmic sperm injection (ICSI).After treatment with Puregon, chorionic gonadotropin (HG) is usually administered to induce the final stage of follicular maturation, the resumption of meiosis and ovulation.

Composition

Foliotropin beta (recombinant) + auxiliary substances.

Pharmacokinetics

After intramuscular or subcutaneous administration of Puregon Cmax, FSH in the blood plasma is achieved within 12 hours. Due to the gradual release of the drug from the injection site and prolonged T1 / 2 (12 to 70 hours, an average of 40 hours), the FSH content remains elevated for 24- 48 h, and therefore repeated administration of the same dose of FSH leads to a further increase in the concentration of FSH by a factor of 1.5-2 compared to a single administration. This allows to achieve a therapeutic concentration of FSH in the blood.

Pharmacokinetic parameters after IM and / or injection of Puregon are not significantly different. In both ways, the bioavailability of the drug is about 77%. Recombinant FSH is biochemically similar to FSH isolated from human urine and similarly distributed, metabolized and excreted from the body.

Indications

Treatment of female infertility in the following cases:

• anovulation (including polycystic ovary syndrome (PCOS)) in women who are insensitive to clomiphene);
• induction of superovulation, for induction of multiple development of follicles during artificial insemination (for example, in IVF / PE, VMI and ICSI techniques).

Forms of release

Solution for intramuscular and subcutaneous injection 50 IU, 100 IU, 150 IU and 200 IU (injections in ampoules for injection).

A solution for subcutaneous administration of 300 IU, 600 IU and 900 IU.

There are no other dosage forms, be it pills or capsules.

Instructions for use and reception scheme

The treatment with Puregon should be initiated under the supervision of a physician with experience in the treatment of infertility.

The dose should be selected individually depending on the response of the ovaries, under the supervision of ultrasound and the concentration of estradiol.

Puregon is effective at a lower total dose and shorter treatment time than necessary for maturation, compared to FSH obtained from urine, which minimizes the risk of ovarian hyperstimulation.

The total experience in the treatment of infertility by in vitro fertilization indicates that success is most likely during the first 4 courses of therapy and subsequently gradually decreases.

With anovulation, a consistent treatment regimen is recommended, starting with the daily administration of 50 IU of Puregon for at least 7 days. In the absence of ovarian response, the daily dose is gradually increased until follicle growth and / or an increase in the plasma estradiol concentration, indicating an optimal pharmacodynamic response. The optimal daily concentration of estradiol in plasma is 40-100%.

The daily dose thus obtained is then maintained until the preovulation condition is reached. The state of preovulation is determined by the presence of a dominant follicle with a diameter of at least 18 mm (according to ultrasound) and / or extrapyantrum concentrations in the blood plasma of 300-900 picograms / ml (1000-3000 pmol / L).

Typically, to achieve this condition requires 7-14 days of treatment.

After this, the administration of the drug is stopped and ovulation is induced by the administration of HC. If the number of follicles is too high or the concentration of estradiol increases too quickly, i.e. more than 2 times a day for 2-3 consecutive days, then the daily dose should be reduced.Since each follicle with a diameter of more than 14 mm is preovulatory, the presence of several follicles with a diameter of more than 14 mm carries the risk of multiple pregnancies. In this case, HCG is not administered and measures are taken to protect against possible pregnancy to prevent multiple pregnancies.

For the induction of superovulation in the conduct of artificial insemination, various stimulation schemes are used. For at least 4 days, 150-225 IU of the drug is recommended. After that, the dose can be selected individually, based on the response of the ovaries. In clinical studies, it has been shown that it is usually sufficient to use a maintenance dose of 75-375 IU for 6-12 days, but in some cases longer treatment may be required.

Puregon can be used either alone or in combination with an agonist or GnRH antagonist to prevent premature ovulation peak. If GnRH analogues are used, higher total doses of Puregon may be required.

The ovarian reaction is monitored by ultrasound and the determination of the concentration of estradiol in plasma.In the presence of at least 3 follicles with a diameter of 16-20 mm (according to US) and the presence of a good ovarian response (estradiol concentration in blood plasma of 300-400 picograms / ml (1000-1300 pmol / l) per follicle with a diameter of more than 18 mm), induce the final phase of follicular maturation by the administration of CG. After 34-35 hours, aspirate the eggs.

The rules of the drug (like pouring Puregon)

To prevent painful sensations during injection and to minimize leakage of the drug from the injection site, the solution should be slowly administered intramuscularly and subcutaneously. It is necessary to alternate the sites of the SC administration to avoid the development of fatty atrophy. Unused solution should be disposed of.

A napkin may be administered by a woman or her partner who received detailed instructions from a doctor. Self-administration of the drug is permissible only for patients who have good skills and a constant opportunity to consult a specialist.

The drug, produced in cartridges, is designed to be injected with a pen-injector "Puregon Peng". In this case, the drug is administered sc.

When using the pen-injector "Puregon Peng" it is necessary to take into account that the handle is an exact device releasing the dose established on it.It is shown that when using a pen-injector, 18% more FSH is injected than with a syringe. This can be significant, in particular, when changing the injector handle to an ordinary syringe, and vice versa, in one cycle of treatment. Some dose adjustment is especially needed when switching from a syringe to a pen to avoid an unacceptable increase in the dose administered.

The drug, produced in vials, is intended for administration with a syringe.

Stage 1 - Preparation of the syringe

To administer the drug should be used disposable sterile syringes and needles. The syringe volume should be small enough to introduce the prescribed dose accurately. If the solution is opaque or contains mechanical inclusions, it can not be used. The contents of the bottle should be used immediately after puncturing the rubber plug. The solution remaining after a single application is discarded. First, remove the bottle cap valve. Put the needle on the syringe and pierce the rubber stopper of the bottle with a needle. Collect the solution in a syringe and replace the needle with a needle for injection. Holding the syringe with the needle up, gently tap it on the side to expel the air bubbles in the top of the syringe,then press the piston until the air is completely removed, until only the Puregon solution remains in the syringe. If necessary, additional pressure is applied to the piston to establish the volume of the solution to be injected.

Step 2 - Place of introduction

The most suitable place for the n / v introduction - the abdomen around the navel with moving skin and a layer of fat. With each injection, you need to slightly change the injection site. You can inject the drug into other parts of the body.

Stage 3 - Preparation of the site of administration

To reduce the discomfort with the introduction of the needle, you can make a few claps at the site of the proposed injection. Hands should be washed and the site of injection is wiped with a disinfectant solution (eg 0.5% chlorhexidine) to remove surface bacteria. Treat approximately 6 cm around the point where the needle enters, and wait for about a minute to allow the disinfectant solution to dry.

Step 4 - Inserting the needle

Slightly pull the skin. With the other hand, insert the needle at an angle of 90 ° under the surface of the skin.

Step 5 - Checking the correct position of the needle

With the correct position of the needle, the piston is quite difficult to return.

Penetrating into the syringe, the blood indicates that the needle pierced the vein or artery. In this case, take out the syringe, cover the injection site with a tampon with a disinfectant and apply pressure, and the bleeding will stop in 1-2 minutes. Do not use the solution and remove it from the syringe. Start again from the 1st stage, using a new needle and syringe, and a new vial of the drug.

Step 6 - Administration of the solution

Lower the piston slowly and gradually to correctly enter the solution and not damage the skin tissue.

Step 7 - Remove the syringe

Quickly remove the syringe, cover the injection site with a tampon with a disinfectant and apply pressure. Careful massage of this place (with constant pressure) promotes the distribution of the solution of Puregon and helps to avoid unpleasant sensations.

Side effect

• hematoma, pain, hyperemia, edema, itching at the site of injection;
• erythema;
• hives;
• rash;
• itching;
• Ovarian hyperstimulation syndrome (clinical symptoms of mild ovarian hyperstimulation are nausea, diarrhea, bloating and abdominal pain due to venous circulation and irritation of the peritoneum, and ovarian enlargement due to cysts);
• pain, and / or engorgement of the mammary glands;
• spontaneous abortion;
• increased probability of multiple pregnancy;
• increased likelihood of ectopic pregnancy;
• development of thromboembolism.

Contraindications

• tumors of the ovaries, breast, uterus, pituitary and hypothalamus;
• vaginal and uterine bleeding of unknown etiology;
• primary failure of the ovaries;
• ovarian cysts or ovarian enlargement not associated with PCOS;
• violation of the anatomy of the genitalia, incompatible with pregnancy;
• uterine myoma, incompatible with pregnancy;
• decompensated diseases of the endocrine system (for example, thyroid, adrenal or pituitary diseases);
• pronounced impairment of liver and kidney function;
• pregnancy;
• lactation period;
• hypersensitivity to any of the components of the drug.

Application in pregnancy and lactation

The use of Puregon during pregnancy and during breast-feeding is contraindicated. Due to the fact that the clinical data on the use of the drug in pregnancy is not enough, then in the case of unintentional intake during pregnancy, the teratogenic effect of recombinant FSH can not be ruled out.

special instructions

Before the start of treatment, the presence of endocrine diseases (for example, thyroid, adrenal or pituitary diseases) should be excluded.

Induction or stimulation of ovulation with gonadotropic drugs increases the risk of developing a multiple pregnancy. Corresponding dose adjustment of FSH prevents the development of multiple follicles. With multiple pregnancies, there is a higher risk of complications during pregnancy and perinatal period. Before starting treatment, patients should be warned about the possibility of developing a multiple pregnancy.

The first administration of Puregon should be performed under the direct supervision of a physician.

In women who undergo artificial insemination (especially IVF), there are often abnormalities of the fallopian tubes, which increases the risk of developing an ectopic pregnancy. Therefore, it is important to obtain an early ultrasound confirmation of the intrauterine fetal positioning.

In women who undergo artificial insemination, the risk of early termination of pregnancy is higher than with natural conception.

The frequency of congenital malformations with the use of assisted reproductive technologies (ART) can be slightly higher than with natural fertilization. Perhaps this is due to the characteristics of the parents (for example, their age or sperm characteristics), as well as the higher frequency of development of multiple pregnancies with ART. There are no indications that an increase in the risk of congenital malformation is associated with the use of gonadotropins.

Before the start of treatment and regularly during the treatment should be carried out ultrasound to monitor the development of follicles and determine the concentration of estradiol in the plasma. In addition to the development of too many follicles, the concentration of estradiol in plasma can grow very rapidly (ie, more than 2 times a day for 2-3 consecutive days), reaching extremely high values. The diagnosis of ovarian hyperstimulation can be confirmed by ultrasound. Transient abnormalities in the results of liver functional tests may indicate a violation of liver function, which may be accompanied by morphological changes in liver biopsy, as reported in connection with the ovarian hyperstimulation syndrome.

Women from recognized risk groups for thrombosis, for example, with an appropriate personal or family history, severe obesity (body mass index> 30 kg / m2) or diagnosed thrombophilia, may be at increased risk of venous or arterial thromboembolism in gonadotropin therapy even without concomitant hyperstimulation syndrome ovaries. When treating such women, it is necessary to compare the probability of successful induction of ovulation and the possible risk of complications. However, it should be noted that pregnancy itself is accompanied by an increased risk of thrombosis.

Puregan can contain traces of streptomycin and / or neomycin. These antibiotics can cause a hypersensitivity reaction.

Impact on the ability to drive vehicles and manage mechanisms

Not detected.

Drug Interactions

The simultaneous use of Puregon and clomiphene can increase the response of the ovaries.

After desensitization of the pituitary gland with GnRH agonists, a higher dose of Puregon may be required to achieve sufficient ovarian response.

Pharmaceutically incompatible with other medicines.

Pureghon drug analogues

There are no structural analogs to the active substance of Puregon.

Analogues on the pharmacological group (funds for the treatment of female infertility):

• Biel;
• Bromergon;
• Buserelin;
• Buserelin depot;
• Buserelin Long;
• Vero Danazol;
• Gonadotropin is chorionic for injection;
• Dianodiol;
• Danol;
• Decapeptil;
• Diferelin;
• Dostineks;
• Duphaston;
• Clomid;
• Clomiphene;
• Clostilbite;
• Luveris;
• Mastodinone;
• Menogon;
• Menopur;
• Metovit;
• Metrodin HF;
• Milife;
• Novofen;
• Non Ovlon;
• Ovitrel;
• Pergonal;
• Pyrogenal;
• Pregnil;
• Profession;
• Serofen;
• Serpafar;
• Sinestrol;
• Tamoxifen;
• Horagon;
• Humegon;
• Cigapan;
• Egestenol;
• Ethinyl estradiol tablets.

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